| CTRI Number |
CTRI/2025/05/087013 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Smoking Affects Salivary Markers in Gum Disease A Clinical Study on ICTP and IL 17 Levels |
|
Scientific Title of Study
|
Evaluation of the impact of the salivary level of ICTP and IL17 in periodontitis patients with and without smoking a randomised control clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sahu |
| Designation |
Post-graduate student |
| Affiliation |
Department of Periodontology and implantology, government dental college and hospital, Raipur |
| Address |
Department of periodontology and implantology, Government Dental College and Hospital, near Marhi Mata Mandir Mekahara Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770875788 |
| Fax |
|
| Email |
neha250579@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyoti Wasti |
| Designation |
Associate professor |
| Affiliation |
Department of periodontology and implantology, Government Dental College and Hospital, Raipur |
| Address |
Department of periodontology and implantology, Government Dental College and Hospital, near Marhi Mata Mandir Mekahara Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
9826322475 |
| Fax |
|
| Email |
Jyotiwasti@YAHOO.IN |
|
Details of Contact Person
Public Query
|
| Name |
Neha Sahu |
| Designation |
Post-graduate student |
| Affiliation |
Department of Periodontology and implantology, government dental college and hospital, Raipur |
| Address |
Department of periodontology and implantology, Government Dental College and Hospital, near Marhi Mata Mandir Mekahara Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770875788 |
| Fax |
|
| Email |
NEHA250579@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, Raipur Chhattisgarh |
| Multidisciplinary unit, Dr. Bhimrao Ambedkar hospital, mekahara Raipur Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Neha Sahu |
| Address |
Government dental college and hospital, raipur chhattisgarh India 492001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Sahu |
Government dental college and hospital, Raipur |
Department of periodontology and implantology, Government Dental College and Hospital, near Marhi Mata Mandir Mekahara Raipur Chhattisgarh, India. 492001
Raipur
CHHATTISGARH |
8770875788
NEHA250579@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE INSTITUTIONAL ETHICAL COMITTEE RAIPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
control group with healthy subjects |
Subjects without any evidence of periodontal and systemic disease. Healthy control group where no sites with 3 mm probing pocket depth (PPD) and attachment loss.
ICTP and IL-17 levels are measure before and after 6 weeks of non surgical periodontal therapy using ELISA KIT |
| Comparator Agent |
Periodontitis Patient with and without smoking habit |
The following clinical parameters will be recorded for all the patients
Probing Pocket depth (PPD)
Gingival Bleeding index (GBI)
Plaque index (PI)
Clinical attachment level (CAL)
and ICTP and IL-17 level are accessed using ELISA kit before and after 6 week follow ups after non surgical periodontal therapy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Outpatients at the hospital within the age group of 18-60 years.
2.Person who are systemically healthy.
3.No history of anti-microbial therapy for the past three months.
4.Able to provide written informed consent and understand the study protocol
|
|
| ExclusionCriteria |
| Details |
1.Pregnant ladies and Lactating Mothers.
2.Patient with Smokeless tobacco habit.
3.Patients with history of systemic disease. Any underlying systemic disease will have effect on periodontal status.
4.Patients who have undergone periodontal therapy or antibiotic therapy in the past 6 months or any other drugs as there will be effect on the periodontal status.
5.Presence of any pre-existing oral infected condition. For e.g. pulpal pathosis.
6.Any patient undergoing radiation therapy.
7.History of any form of periodontal treatment in the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be decrease in salivary IL-17 levels & ICTP levels in periodontitis patients & periodontitis patient having smoking habit after nonsurgical periodontal treatment. |
1 year 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non-surgical periodontal treatment will have significant impact on bone resorption marker i.e IL-17 level & ICTP levels and will be well correlated with clinical parameters of periodontal tissue destruction. |
1 year 6 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-07-2025 and end date provided 30-07-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| | Periodontitis is an infectious disease of the tissues surrounding the teeth, occurring in about 50% of the population and resulting in significant debilitation for about half of these persons. Therefore, the prevention or treatment of local inflammatory disease (periodontitis) may be an important factor in the control of systemic inflammatory conditions. Traditional methods used in the diagnosis of periodontal disease include assessments of gingival inflammation (e.g., bleeding on probing) and periodontal tissue destruction (e.g., probing depth [PD], clinical attachment level [CAL]). Advantage associated with these methods include being easy to use, cost effective and relatively non- invasive. However, the major disadvantage of these techniques is that they are static diagnostic parameters, indicating disease history and not the current disease status. Therefore, these methods cannot identify highly susceptible patients or actively deteriorating sites. So, there is a need for a biomarker that can be correctly & easily quantified and which can predict the diseased status of the periodontium much before any considerable damage is done to the periodontal structures including the alveolar bone. Such a biomarker will effectively enhance the prediction and treatment plan there by greatly improving the outcome of the periodontal treatment. ICTP concentration is currently being used as a diagnostic marker of active bone resorption in many systemic metabolic bone diseases such as postmenopausal osteoporosis, myxoedema, thyrotoxicosis, and primary hyperparathyroidism; The value of pyridinoline cross-links as markers of bone turnover is because of their specificity for bone. Interleukin -17 (IL -17) is a multifaceted cytokine with diverse roles both in immune -protection and also immunopathology.4 The pro-inflammatory cytokine IL-17, and IL-17 producing CD4+ T cells (also called Th17 cells) have been shown to play an role in many inflammatory diseases, there is increasing evidence of the presence of IL-17 and Th17 cells in human Periodontitis lesions and this may be associated with disease severity. |
|
| Saliva acts as a cumulative diagnostics fluid in the oral cavity containing not only the constituents of the exocrine salivary glands but also the gingival crevicular fluids. Thus, it has the advantage of providing overall idea about periodontal health status, in such scenario, whole saliva and its contents represent a promising diagnostic fluid for the screening of periodontal disease.3 Saliva contains biomarkers that can be used for diagnosing local and systemic diseases and monitoring the effect of treatment, Changes in the content of saliva may be indicative of pathological changes in periodontal tissues. One-third of the world’s adult population are smokers (57% of these are men, 43% are women), It is predicted that in 20 years this yearly death rate from tobacco use will be more than 10 million people; Smoking in developing countries is rising by more than 3% a year.7 The relationship between smoking and periodontal health was investigated as early as the middle of last century, smoking is an independent risk factor for the initiation, extent and severity of periodontal disease.7 Grossi et al (1995) found that tobacco smoking was strongly associated with both attachment and bone loss. Smokers are more susceptible than non-smokers to advanced and aggressive forms of periodontitis (Haber et al. 1993, Ketabi & Hirsh 1997). In smokers, there seems to be a relationship between periodontal attachment loss, number of cigarettes smoked daily (Martinez-Canut et al. 1995), and number of years of tobacco consumption (Haber & Kent 1992).8 The present study involves the direct measurement of a potential biomarker in the whole human saliva of a bone specific molecule called ICTP (pyridionline cross-linked carboxy-terminal telopeptide of type I collagen) and IL-17, as to the best of our knowledge, very few studies have been conducted to know the relationship between smoking, inflammatory periodontal disease, and salivary ICTP and IL-17 levels and their relationship has not been clarified. Our hypothesis is NSPT will reduce the level of ICTP and IL-17 in periodontitis patient. Hence, this dissertation aims to evaluate the concentration of the salivary ICTP levels and interleukin-17 levels in healthy patients, patient with periodontitis with and without smoking habit. | |